BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAWIRE¿ AND WIRECLIP¿ TORQUER

    MDR report key: 6128653 · Received November 28, 2016

    Report

    Report Number
    2134265-2016-10641
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-10695, 2134265-2016-10663. IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MIDDLE LEFT ANTERIOR DESCENDING ARTERY(LAD). A GUIDE WIRE WAS ADVANCED AND A NON-BSC BALLOON CATHETER WAS SELECTED TO THE DILATE LESION. THE BALLOON WAS DILATED BUT UNABLE TO EXPAND THE LESION DUE TO EXCESSIVE CALCIUM. NO VISIBLE CHANGE IN THE ANGIOGRAM OR DISSECTION WAS NOTED. A 330CM ROTAWIRE¿ WAS ADVANCED AT THE DISTAL LAD AND A 1.25MM ROTALINK¿ PLUS WAS ADVANCED. THE FIRST ABLATION WAS PERFORMED AT 160,000 RPM WITHOUT ISSUES; HOWEVER, DURING THE THIRD ABLATION, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND COMPLAINED OF CHEST PAIN. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THAT THE PATIENT HAD SLOW FLOW- TIMI 1 OR 2 FLOW DOWN THE LAD. THE ROTALINK¿ PLUS WAS REMOVED VIA DYNAGLIDE MODE. VASODILATORS WERE ADMINISTERED AND BLOOD FLOW HAD IMPROVED. THE ROTAWIRE¿ WAS EXCHANGED TO A WORKHORSE WIRE AND DILATED THE LESION WITH A 2.5X15MM NON-BSC BALLOON. A NON-BSC IMAGING CATHETER WAS ADVANCED TO VISUALIZE THE LUMEN OF THE LAD. A 2.50 X 38 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS SUCCESSFULLY IMPLANTED. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED NO DISSECTION OR PERFORATION. HOWEVER, THE PATIENT'S PAIN AND SHORTNESS OF BREATH IMMEDIATELY INCREASED AND THE SYSTOLIC BLOOD PRESSURE DROPPED BELOW 100MMHG. IN THE NEXT FEW MINUTES, THE PATIENT WENT INTO ASYSTOLE AND LOST EKG AND BLOOD PRESSURE. CARDIOPULMONARY RESUSCITATION WAS IMMEDIATELY PERFORMED; HOWEVER, THE PATIENT WAS NOT ABLE TO BE REVIVED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781630 ROTAWIRE¿ AND WIRECLIP¿ TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H802228240022

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death